Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001252707
Ethics application status
Approved
Date submitted
12/09/2022
Date registered
19/09/2022
Date last updated
19/09/2022
Date data sharing statement initially provided
19/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effect of minimal plastics exposure strategies on Plastic-Associated Chemicals (PAC) Excretion in healthy adults.
Scientific title
Examining the effect of minimal plastics exposure strategies on Plastic-Associated Chemicals (PAC) Excretion in healthy adults.
Secondary ID [1] 307938 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The P.E.R.T.H Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endocrine disruption 327587 0
Inflammation 327588 0
Condition category
Condition code
Inflammatory and Immune System 324675 324675 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Many plastic products contain endocrine disrupting chemicals, in this trial referred to as plastic-associated chemicals or PAC. This trial is particularly concerned with bisphenols and phthalates where humans are exposed through contact with food contaminated either by the leaching of plasticisers from packaging or contaminated with plastic particles. In addition, commonly used personal care and cleaning products, and materials used in construction, may contain PAC which can be inhaled or absorbed through the skin.

In this trial low PAC food is defined as minimally processed (according to NOVA Classification) fresh produce where the supply chain is either known to be free, or likely to be free of potential plastic contamination. Foods that are canned, pickled, use plastic storage containers will be either avoided or substituted, for example olive oil, where possible with glass. Plastic utensils used in the preparation of food will be substituted for non-plastic. While foodstuffs will be supplied, participants will be free to assemble meals of their choice.

Commonly used personal care products e.g. shampoo and soaps that are declared to be free of PAC will also be used in the study.

The participants (N=60) will attend the research clinic in the Harry Perkins Institute for Medical Research (Nedlands, Western Australia) (Visit 1) and, following consent, will be randomised to one of five parallel groups, (n=12 per group), to receive an low plastic-associated chemicals (PAC) intervention in their homes, over a 7-day period. The total duration of the study is between 8 and 21 days. Two visits of up to two hour's duration, over a 14-day period, at the Harry Perkins Research Institute will be required. In addition there will be five telephone interviews over the study period of up to one hour's duration.

The 60 participants will be randomised into one of the following groups:
Group 1: low PAC food only
Group 2: low PAC food + low risk utensils + low risk food preparation practices
Group 3: low PAC personal products only
Group 4: low PAC food + low risk utensils + low risk food preparation practices + low PAC personal products
Group 5: Control group

Following randomisation at Visit 1, participants will be assigned to a research dietitian who will, depending on participant allocation to the intervention, provide education concerning the avoidance of certain foods, food preparation and cooking practices, and personal care products, and supply participants with a list of the approved foods and products they can order from the approved supplier (the ‘Providore’). Some utensils will be supplied to substitute the participants own e.g. a metal kettle and glass containers. For consistency of communication and rapport a single dietitian will be the point of contact for the participant over the intervention period.

At Visit 1 participants will also provide a spot urine sample and a blood sample will be drawn by the study nurse. On the last day of the intervention, participants will attend the clinic (Visit 2) for another blood draw. Biological samples specifically, urine, stool and nasal lavage samples will be self-collected at three time points by the participants who will be provided (at Visit 1) with sample containers and storage boxes fit for purpose to retain their samples prior to research clinic attendance on day 7 (Visit 2).

The interventions

Intervention A, Dietary intervention
Participants from Groups 1, 2 and 4 will select fresh foods and condiments from a list assembled by the dietetic research team, and sourced from suppliers approved by the appropriate Western Australian local regulatory authority. The senior dietitian will liaise directly with the suppliers and the contracted Providore. Food stuffs available for the participant to order will allow for participant preference (e.g. sufficient choices for vegetarian vs omnivore diets), balanced and nutritious. Each participant will be assigned to a single dietitian as a contact person throughout the intervention period. The researchers will pay for the food and assist with ordering from the nominated Providore, who will arrange delivery to the participants’ homes. Participants from Groups 2 and 4 will, in addition to consuming exclusively the provided low PAC food, use non-plastic cooking utensils provided by the researchers, and follow guidance concerning the preparation of their food. Menu cards will be made available for convenience but participants will be free to assemble meals of their choice. Group 1 participants will not be asked to change their food preparation methods or utensils.

Should results of urine tests for PAC indicate contamination from an unexpected source, it may be necessary to test some food products retrospectively. Therefore it is planned for some trial foods to be sampled at the nominated Providore by a qualified food scientist, and in liaison with the senior dietitian.

Delivery of products to participants’ homes will take place the day before the intervention begins, and at pre-determined time-points throughout the study, as required. Participants will be supplied with a comprehensive schedule, and instructions for the 7-day intervention, and contacted at four pre-agreed times for assessments. The 24HR-DR conducted by telephone interview during the intervention week will facilitate assessments of deviations from the protocol, and enable the assessment of energy, macro and micronutrient intake.

Intervention B, Personal care products intervention

Participants from Groups 3 and 4 will use only those products supplied by the dietetic research team. Personal care products include, but are not limited to shampoo, conditioners, face moisturisers, cleansers, serums, make-up and sunscreens, deodorant, tampons and applicators. The 15-item 24HR-PPR recall questionnaire for personal care products usage will be sent to participants as a scheduled electronic survey.

The assessment tools

24-hour dietary recall interview (24HR-DR)
This assessment is a researcher-administered, computer-assisted, 24-hour dietary recall interview. The method assesses dietary intake on the preceding 24-hour period. The method is adapted to gather additional information concerning the packaging, storage, and preparation of food by the participants. Trained dietitians will carry out the interviews by either telephone or video (Microsoft Teams) to provide the option of face-to-face communication. The interviews will vary in length between 15 and 60 minutes depending on the stage of the study, and the complexity of each participants’ diet. They will be carried out three times during the 7-day intervention, and a fourth time on day 8.

24-hour personal care product recall (24HR-PPR)
This is a self-administered, pilot questionnaire for the 24-hour recall of personal care products use. This assessment will be sent to participants as an automated, scheduled survey three times during the 7-day intervention and a fourth time on day 8. The questionnaire consists of 15 questions and will take between 2 and 5 minutes to complete.

Qualitative research

Up to 21 days following the 7-day intervention, trained interviewers will conduct short tele-interviews with participants to assess the tolerability and feasibility of the trial interventions, and uncover aspects that will encourage participation and adherence to future studies. An interview guide consists of a series of closed and open-ended questions. Data will be collated in a qualitative software and analysed be three researchers independently of others.

Adherence/Fidelity

Adherence to the interventions will be captured during the 24HR-DR interviews, and using the 24HR-PPR questionnaire which will be administered three times during the 7-day intervention, and a fourth time on day 8. It is expected that the qualitative interviews will also capture any difficulties experienced by the participants that might have affected their adherence to the intervention and procedures.
Intervention code [1] 324395 0
Treatment: Other
Comparator / control treatment
Control group
The participants in the control group will not receive the intervention nor be expected to change behaviour. They will undergo the same assessments as the intervention groups to capture their food purchasing, food preparation and personal product use over the 7-day intervention period.
Control group
Active

Outcomes
Primary outcome [1] 332496 0
Completion of the intervention study as evidenced by an audit of the study database indicating complete ascertainment of data from 60 participants.
Timepoint [1] 332496 0
Three months following commencement of the trial.
Secondary outcome [1] 413736 0
Completed evaluation of the 24-hour computer-assisted dietary recall interview (24HR-DR) as evidenced by an audit of the study database.
Timepoint [1] 413736 0
Three months following the commencement of the trial.
Secondary outcome [2] 413739 0
Presence of metabolites of plastic-associated chemicals (PAC) determined by urine analysis reported for N=60 participants recruited.
Timepoint [2] 413739 0
Six months following commencement of the trial.
Secondary outcome [3] 413848 0
Tolerability and feasibility of the interventions is indicated by data gathered from individual semi-structured telephone interviews between researchers and participants.
Timepoint [3] 413848 0
Four months after the commencement of the study.

Eligibility
Key inclusion criteria
1. Healthy biological males or healthy, non-pregnant, non-lactating biological females aged 18 to 60 years.
a. For female participants at least one of the following must apply
b. Not of childbearing potential – surgical sterile or postmenopausal (no menses last 12 months and FSH greater than 40 mIU/mL)
c. Childbearing potential and agrees to practice true abstinence, is in a same-sex relationship or agrees to use highly effective contraception during the course of the study (hormonal contraception with condom/IUD) or vasectomised male partner.
2. Body mass index between less than or equal to 18.5 and greater than or equal to 34.9 kg/m2. If outside this range, eligible at investigator’s discretion.
3. Currently healthy (mentally and physically) in the opinion of the investigator based on a comprehensive clinical assessment (detailed medical history and physical examination), electrocardiogram (ECG), vital signs, and laboratory investigations (hematology, clinical chemistry, coagulation, and urinalysis).
4. Lives in the Perth Metropolitan Area.
5. Ability to give written informed consent.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of drug or alcohol abuse in the past 24 months. Alcohol abuse defined as greater than 21 units/week for males, greater than 14/units for females.
2. Current regular smoker or e-cigarette use. Social smokers ( less than 3 nicotine/tobacco products in the last 3 months) can be included if abstaining for the duration of the study.
3. Currently pregnant or planning pregnancy during the course of the study as assessed by pregnancy testing carried out during screening.
4. Not suitable for the study for any other reason, as determined by the investigator.
5. Acute infection, surgery, vaccination, or other inflammatory process in the previous 2 weeks. Minor procedures are exempt at investigator’s discretion.
6. Evidence of moderate or greater renal impairment at screening, as indicated by an estimated creatinine clearance of less than 60 mL/min using the Cockcroft-Gault equation.
7. Clinically significant abnormal laboratory tests, as determined by the investigator, not otherwise mentioned.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book that is uploaded to computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size selected, 12 participants per group i.e. N= 60 in total, is considered adequate for a feasibility study. Information on the dropout rate and variability in the PAC excretion measures collected in this feasibility study will be used to calculate sample size for a future disease focused intervention study.

Statistical analysis

Plastic-associated chemical excretion will be summarised, as measured at baseline, during and at the end of the intervention, as well as differences between these time points in the five study arms using means and standard deviations. The dropout rate will be reported. General linear mixed models will be used to compare the changes in PAC excretions between the five groups. Group will be included as a fixed effect and participant ID will be included as a random effect, and an appropriate correlation structure determined. Model assumptions will be tested, and appropriate transformations will be employed if and where necessary. Estimated mean differences between groups and 95% confidence intervals will be reported and relevant p-values will be provided.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2023
Actual
Date of last participant enrolment
Anticipated
24/04/2023
Actual
Date of last data collection
Anticipated
22/05/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 38487 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312208 0
Charities/Societies/Foundations
Name [1] 312208 0
The Minderoo Foundation
Country [1] 312208 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 313733 0
None
Name [1] 313733 0
Address [1] 313733 0
Country [1] 313733 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311589 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 311589 0
35 Stirling Hwy, Crawley WA 6009
Ethics committee country [1] 311589 0
Australia
Date submitted for ethics approval [1] 311589 0
08/06/2022
Approval date [1] 311589 0
18/08/2022
Ethics approval number [1] 311589 0

Summary
Brief summary
The fundamental premise underpinning the research is that exposure to PAC, combined with genetic and lifestyle factors, creates chronic and systemic inflammation that underpins cardiometabolic conditions. The challenge is to demonstrate that decreasing exposure to PAC will reduce inflammation, and there are methodological issues to overcome.

In this study, we will implement interventions to determine if removing putative sources of PAC exposure found in food and personal care products results in reduced excretion of PAC in urine. The interventions will be carried out in the participants’ homes with the support of registered dietitians under the supervision of a senior dietetic researcher.

Sixty participants will be randomised into one of the following groups: Group 1: low PAC food only; Group 2: low PAC food + low risk utensils + low risk food preparation practices; Group 3: low PAC personal products only; Group 4: low PAC food + low risk utensils + low risk food preparation practices + low PAC personal products; Group 5: Control group.

We hypothesise that this approach will demonstrate whether intervention A (low PAC ‘diet’) has an impact on urinary excretion of PAC (the response), whether intervention B (low PAC personal products) has an impact on the response, and whether there is any synergistic or antagonistic impact on the responses from combining the two interventions. That is, we will determine whether both intervention A and intervention B together provide a larger/smaller impact than the sum of the impact from each intervention alone. This design is statistically and economically efficient as it reduces the number of replicates needed and addresses many statistical hypotheses including the potential interactive effect of both interventions.

The findings of this trial are expected to inform the optimal design for a future disease-focused randomised controlled trial testing the hypothesis that decreasing PAC exposure reduces risk factors for cardiometabolic disease.
Trial website
Trial related presentations / publications
Public notes

At the time of recruitment, proof of immunisation against COVID_19 (SARS-CoV-2), will be required according to WA Health Department Guidelines.

Plastic-associated chemicals exposure questionnaire (PACeQ)
The PACeQ is a self-administered online questionnaire aiming to uncover behaviours or practices that may lead to personal exposure to PAC by way of ingestion, inhalation, or absorption. Responses to the questions are scaled. The PACeQ is an electronic survey using the REDCap platform. The pilot questionnaire contains 87 items, and will take approximately 15 minutes to complete.

Contacts
Principal investigator
Name 121630 0
Prof Michaela Lucas
Address 121630 0
Level 5, Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009
Country 121630 0
Australia
Phone 121630 0
+61 466553256
Fax 121630 0
Email 121630 0
Michaela.Lucas@uwa.edu.au
Contact person for public queries
Name 121631 0
Prof Michaela Lucas
Address 121631 0
Level 5, Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009
Country 121631 0
Australia
Phone 121631 0
+61 466553256
Fax 121631 0
Email 121631 0
Michaela.Lucas@uwa.edu.au
Contact person for scientific queries
Name 121632 0
Prof Michaela Lucas
Address 121632 0
Level 5, Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009
Country 121632 0
Australia
Phone 121632 0
+61 466553256
Fax 121632 0
Email 121632 0
Michaela.Lucas@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage of the study we will not make the decision on sharing IPD but this decision may be reviewed in the future.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.